Existing catheter technology results in numerous health and safety issues for patients, medical personnel, and the community at large. The technology of indwelling urinary catheters has barely changed over the last 50 years. Improvements in existing urinary catheter systems are highly desirable. A urinary catheter drainage system is made up of the catheter itself which is inserted into the bladder, and the urine collection device which attaches to the catheter with a tubing and collects the urine into some type of receptacle depending on its purpose. One example of a urine collection device is a bedside drainage bag, which is usually a tube connected to the catheter leading to a large bag that hangs on the bedside to collect the urine. Another example is a leg bag which is worn when a patient is up and around and is a shorter tube attached to a smaller bag which is attached to the leg and collects urine.
The complications associated with catheterization include, catheter associated urinary tract infections (CAUTI's), blockage, (due to struvite or biofilm formation), bladder atony, (causing a short term or permanent inability to void), bladder spasms, and thickening of the bladder wall from long term use.
In addition to direct patient complications, there are numerous safety issues related to current catheter systems both in the inpatient setting, and the home health setting. Present systems put clinicians at risk of occupational injury related to bio-hazardous waste exposure. Clinicians are frequently sprayed with urine when attempting to irrigate clogged catheters when pressure from the irrigation syringe causes swelling of the catheter and spray back to occur. Because the current available catheter technology demands that the catheter be disconnected from the urine collection device in order to irrigate the system, leaking or spilling of urine occurs during these procedures. When these spills and splashes occur, clinicians, other patients, and the community at large are put at risk for cross contamination and the spread of infection, including antibiotic resistant pathogens.
In summary, most of the problems listed above arise, at least in part, from two primary problems with existing catheter systems: (1) Current catheter systems do not allow for the maintenance of a closed, aseptic system; and (2) Current catheter systems do not allow the bladder to fill and empty in a normal fashion.
About 30% of CAUTI's are shown to be caused by intraluminal bacterial biofilm formation. The primary way bacteria enter the inner lumen to cause infection is by entering the drainage end of the catheter and ascending the inner lumen to the bladder. The 2009 CDC Healthcare Infection Control Practices Advisory Committee (HICPAH) recommended a closed urinary drainage system with all catheters as a high priority recommendation, essential for all healthcare organizations caring for patients with catheters. They found both older and more recent data indicating that disconnection of the urine collection device from the catheter is a risk factor for bacteriuria.
In order to maintain a closed urinary drainage system, the catheter must not be disconnected from the urine collection device. The most common reason for disconnecting the catheter from the urine collection device is when the catheter needs to be irrigated. Many catheters need to be irrigated several times a day exposing the patient to infection and the clinician to bio-hazardous waste up to several times a day.
In order to address the specific problem associated with closed irrigation of a catheter, Russo U.S. Patent Application Pub. No. US 2006/0064065 discloses a closed system irrigation connector for urinary catheters which allows for a closed irrigation of the catheter wherein a silicone diaphragm opens when an irrigation device is attached, and closes when it is removed. But the device of Russo does not provide for an aseptic irrigation procedure. In order to maintain an aseptic closed system, anything entering said system must be free of bacteria. This means that the system must have entrance portals that are closed while not being accessed and that are fully sanitizable prior to access.
In order to effectively sanitize a surface, the surface must be easily and fully accessible to apply the needed friction and anti-infective agent. The surface must not have crevices or difficult to reach places where bacteria can the friction and antimicrobial agent. The plastic entrance port disclosed by Russo does not have a flat, easily sanitizable surface, but has a crevice that cannot be effectively sanitized. Bacteria hiding on this un-sanitizable surface can enter the system during irrigation and infect the patient.
The second major problem with current catheter systems is that they drain the bladder constantly, not allowing it to fill and empty in a normal manner. This leaves a pool of concentrated, stagnant urine in the neck of the bladder below the drainage holes on the catheter. This stagnant urine serves to create a perfect breeding ground for bacteria.
Catheter blockage is another problem with “constant drain” catheter systems caused by the buildup of biofilm and salt crystals at the opening of the catheter. Much like a stalactite, the high pH, high mineral fluid in the neck of the bladder provides the perfect environment for this to occur.
Bladder spasms can be caused by several factors. The most frequent cause is CAUTI as already discussed above. The bladder wall becomes irritated and even swells and spasm occurs. The loss of normal stretching and contracting of the detrusor can also cause spasm. Irritation from highly concentrated, and high pH urine could also be factor. Bladder wall thickening has also been observed in long-term catheterizations and may be a result of the increasing. Catheter related bladder atony is another complication associated with not allowing the bladder to fill and empty. When the bladder no longer fills and empties in a normal fashion, the detrusor muscle can atrophy causing a temporary or even permanent inability to void after catheterization. These problems could be solved, at least in part by allowing the bladder to fill and drain in a more normal fashion.
Many types of valved catheters and universal connections exist which allow for intermittent draining and retention of the bladder. None of the prior art in this area discloses sanitizable surfaces on entry ports leading from the outside to the inside of the closed urinary drainage system. These systems complicate the problem by introducing bacteria into what should be a closed system. A system, method, and apparatus is needed that allows for aseptic irrigation and urine sampling while maintaining a closed system, and allows for control of urine flow, allowing the bladder to fill and empty as needed or prescribed.